MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065000095

Device Problems Vibration (1674); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported cutting failure of a probe occurred during cataract/ vitrectomy combination procedure.When the cutter was actuated, the cutting was unsteady, and the vibration was strange.The condition of aspiration and actuation was unknown.The procedure was completed after replacing the cutter with another one.There was no patient harm.

Manufacturer Narrative

Two opened probes were received, without a tip protector, in a bubble bag.Sample 1: the sample was visually inspected and found to be nonconforming with orange/brownish foreign material on the port face, welded cap and in the port.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for actuation and aspiration, no vibration observed.The sample was found to be nonconforming for cut.The probe was disassembled and the components inspected.Excessive wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks observed at cutting edge and under the port of the inner cutter.Orange/brownish foreign material observed on port face and other location on the inner cutter.Dried clear foreign material observed on the port face.Sample 2: the sample was visually inspected and found to be nonconforming with orange/brownish foreign material on the port face and welded cap.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for actuation and aspiration, no vibration observed.The sample was found to be nonconforming for cut.The probe was disassembled and the components inspected.Excessive wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks observed at cutting edge, under the port of the inner cutter and a couple other locations along the inner cutter.Orange/ brownish foreign material observed on port face and other location on the inner cutter.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The complaint evaluation does not confirm that both probes returned had a strange vibration.The evaluation confirms that both probe samples had a cut failure.The cause of the cut failure observed on both probe samples is the observed gouge marks on the cutting edge of the inner cutter of the probe.The root cause of the gouge marks observed on the cutting edge as well as the foreign material observed is due to the excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that the probe has experienced a use much greater than this typical timeframe.The excess usage of the probe will wear and damage the inner cutter such that the cutter function becomes poor, bent, or does not function at all.The reported strange vibration was not confirmed on both probe samples, and it appears that the observed cut failure observed on both probe sample was due to excessive use of the probe by the user; therefore, no specific action with regard to this complaint was taken by the manufacturing site.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15444355
• MDR Text Key: 303558050
• Report Number: 1644019-2022-00753
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380650000958
• UDI-Public: 00380650000958
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065000095
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM